OnCo
companiesCompany

Amgen

Amgen invented the BiTE T-cell engager format and the first KRAS inhibitor.

Blinatumomab, tarlatamab (first solid-tumour T-cell engager with OS benefit), sotorasib, bemarituzumab (FGFR2b), xaluritamig (STEAP1×CD3), Imlygic.

Headquarters
Thousand Oaks, CA, US
Type
pharma · AMGN

Products

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ApprovedBispecific T-cell engager (CD19×CD3)
Blinatumomab · Blincyto

Blinatumomab was the first T-cell engager (2014), and is now given to children and adults with leukaemia even when in remission, because it improves survival.

ApprovedBispecific T-cell engager (DLL3×CD3)
Tarlatamab · Imdelltra

The first T-cell engager to improve survival in a common solid tumour, small-cell lung cancer.

ApprovedSmall-molecule inhibitor (KRAS G12C)
Sotorasib · Lumakras

Sotorasib (Lumakras) was the first drug to hit KRAS, approved in 2021 after four decades of failure.

ApprovedOncolytic virus (HSV-1)
Talimogene laherparepvec · Imlygic

Talimogene laherparepvec (T-VEC, Imlygic) was the first approved oncolytic virus (2015), injected into melanoma skin lesions.

Phase 3Monoclonal antibody (anti-FGFR2b)
Bemarituzumab

Bemarituzumab is an antibody against FGFR2b, a growth receptor overproduced in about a third of stomach cancers. It improved survival early in its phase 3 trial, but the gain faded with longer follow-up.

ApprovedProteasome inhibitor (irreversible)
Carfilzomib · Kyprolis

Carfilzomib is a second-generation proteasome inhibitor with less nerve damage but more heart and blood-pressure effects.

ApprovedMonoclonal antibody (anti-EGFR)
Panitumumab · Vectibix

Panitumumab is a fully human EGFR antibody, the preferred first-line partner for chemotherapy in left-sided, RAS-normal bowel cancer after the PARADIGM trial.

Phase 3Bispecific T-cell engager (STEAP1×CD3, XmAb 2+1)
Xaluritamig

Xaluritamig is Amgen's T-cell engager for prostate cancer, now in two phase 3 trials, aiming to do for prostate cancer what tarlatamab did for small-cell lung cancer.

Key papers

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rctNew England Journal of Medicine 2025changed practice
Children's Oncology Group AALL1731: blinatumomab added to chemotherapy for children with standard-risk B-cell ALL

AALL1731 brings immunotherapy into the front-line treatment of the commonest childhood cancer, in the group of children where most relapses were occurring despite good initial risk. Blinatumomab was approved for this use in 2024 and paediatric protocols worldwide are being amended. Whether it can allow less chemotherapy, and its effect on very low-risk children, are the next questions.

rctNew England Journal of Medicine 2024changed practice
ECOG-ACRIN E1910: adding blinatumomab to chemotherapy for adults with B-cell ALL already in MRD-negative remission

E1910 changed the standard of care for adult B-ALL: immunotherapy is now part of front-line consolidation even for patients with no detectable leukaemia, because MRD-negative by flow cytometry does not mean cured. It also demonstrated that a T-cell engager can improve overall survival in a curative setting. Chemotherapy-light or chemotherapy-free regimens built on blinatumomab and inotuzumab are the next step.

rctThe Lancet 2023changed practice
CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug

Patients with KRAS G12C lung cancer that has progressed after chemo-immunotherapy can take an oral KRAS inhibitor instead of docetaxel and gain a somewhat longer time to progression with fewer severe side effects, but should understand that most tumours become resistant within a year and that survival is not improved. KRAS G12C testing is worthwhile, but first-generation inhibitors are a step rather than a cure; combinations and next-generation inhibitors are the active research fronts.

rctNew England Journal of Medicine 2023changed practice
CodeBreaK 300: sotorasib plus panitumumab in chemotherapy-refractory KRAS G12C colorectal cancer

Patients with metastatic colorectal cancer carrying a KRAS G12C mutation (about 3-4% of cases) who have exhausted standard chemotherapy now have a targeted option that works far better than trifluridine-tipiracil or regorafenib. The higher sotorasib dose is clearly superior, and the EGFR antibody is essential because KRAS inhibition alone barely works in bowel cancer. Responses are still modest and short-lived compared with EGFR or ALK inhibitors in lung cancer.

rctNew England Journal of Medicine 2023changed practice
DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer

Patients with small-cell lung cancer that has relapsed after chemotherapy now have a drug that works far better than topotecan or lurbinectedin, and it is the first T-cell engager approved for a solid tumour. Treatment requires inpatient monitoring for the first doses because of cytokine release syndrome, which most centres now manage on a short-stay basis. It does not yet apply to first-line treatment, where trials are ongoing.

Connected

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